Cymbalta®

Cymbalta®, generically duloxetine, is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) that is made by Eli Lilly and Co. and was approved by the Food and Drug Administration (FDA) in August 2004.

Uses and Indications

Available in pill form, Cymbalta® should be taken once daily, at the same time each day, to treat a broad range of conditions including:

• Generalized anxiety disorder
• Fibromyalgia
• Major depression
• Nerve damage and pain resulting from a complication with diabetes

Cymbalta® is not indicated for patients younger than 24 years old, taking MAOI medications, allergic to duloxetine, and/or living with serious liver or kidney dysfunction.

Safety Information for Patients

Like other SSNRIs, Cymbalta® does carry the risk of causing serious side effects for a limited number of patients. Safety warnings on the drug's packaging can help elucidate the range of potential side effects, as can your physician. To minimize the chances of developing serious side effects, be sure to disclose your complete medical history with your doctor before beginning a course of this medication.

Is Cymbalta® Linked to Birth Defects?

A study published in the 2006 New England Journal of Medicine reported that newborns of pregnant women taking Cymbalta® in their third trimester of pregnancy were six times more likely (than infants of mothers not taking an SSRI or SSNRI) to develop a critical, potentially life-threatening lung condition known as persistent pulmonary hypertension (PPHN).

Another study published in the November 2006 edition of Epidemiology suggests that infants born to pregnant women taking Cymbalta® were three times more likely to be born with a birth defect. Other studies have reported finding a link between taking the drug during pregnancy and a newborn developing the following types of birth defects:

• Autism
• Club foot
• Cranial deformities that can cause intracranial pressure, blindness, stroke, or brain damage
• Heart deformities
• Limb deformities
• Pulmonary stenosis
• Spina bifida

Despite the findings of these studies, in December 2011, an FDA warning stated:

• It was premature to definitively conclude that Cymbalta® — rather than some other factor, such as genetic factors or a mother's health — increases the risk of birth defects; and
• More comprehensive and consistent studies needed to be conducted.

There hasn't been a clear connection, because pregnant women are not going to be a part of study to test whether a drug harms their infants. But, according to some researches, there is enough evidence to say that taking Cymbalta® and other similar drugs increase the risk for problems. If your baby is born with a birth defect and you took Cymbalta® or a similar medication during your pregnancy and you were unaware of the possible risk, you may be eligible to file a lawsuit. To learn more, contact Flood Law Group today.